Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126857351 | 12685735 | 1 | I | 20160701 | 20160817 | 20160825 | 20160825 | EXP | US-BAXALTA-2016BLT006021 | BAXALTA | 58.13 | YR | F | Y | 72.50000 | KG | 20160825 | PH | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126857351 | 12685735 | 1 | PS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 30 G, EVERY 4 WK | 125105 | 30 | G | SOLUTION FOR INFUSION | |||||||
| 126857351 | 12685735 | 2 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | UNK | 125105 | SOLUTION FOR INFUSION | |||||||||
| 126857351 | 12685735 | 3 | I | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126857351 | 12685735 | 1 | Immunodeficiency common variable |
| 126857351 | 12685735 | 3 | Infectious mononucleosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126857351 | 12685735 | HO |
| 126857351 | 12685735 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126857351 | 12685735 | Back pain | |
| 126857351 | 12685735 | Dehydration | |
| 126857351 | 12685735 | Drug interaction | |
| 126857351 | 12685735 | Intestinal obstruction | |
| 126857351 | 12685735 | Migraine | |
| 126857351 | 12685735 | Pneumonia | |
| 126857351 | 12685735 | Urinary retention | |
| 126857351 | 12685735 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126857351 | 12685735 | 1 | 201603 | 20160727 | 0 | |
| 126857351 | 12685735 | 2 | 20160713 | 0 |